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FDA 510(k) Application Details - K982216
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K982216
Device Name
Monitor, Breathing Frequency
Applicant
BRAEBON MEDICAL CORP.
63 ACKLAM TERRACE
KANATA K2K 2H7 CA
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Contact
RICHARD A BONATO
Other 510(k) Applications for this Contact
Regulation Number
868.2375
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Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
06/23/1998
Decision Date
09/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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